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Pharmaceuticals - Union Register


Register of orphan medicinal products


Product information

Icatibant acetate

EU orphan designation number: EU/3/03/133   
Active ingredient: Icatibant acetate
Indication: treatment of angioedema
Sponsor: Shire Pharmaceuticals Ireland Limited
Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland
EU Centralised marketing authorisation: A centralised EU marketing authorisation has been obtained under the name Firazyr on 11/07/2008 with the number EU/1/08/461

   Public summary of scientific opinion     EPAR

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
19/02/2003 Orphan designation EMEA/OD/054/02 (2003)615 of 17/02/2003
2/09/2013 Change of name and/or address of sponsor
1/10/2018 Transfer of orphan designation EMA/OD/054/02/T/01 (2018)6432 of 27/09/2018